A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIIa Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）in Monotherapy of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 406
- 主要终点
- HbA1c
研究概览
简要总结
This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise； have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.
详细描述
This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy run-in period. Period 3：A 52-week treatment period (including a 24-week core treatment period and a 28-week extended treatment period).
Period 4: A 4-week safety follow-up period. This study will last for approximately 63 weeks, including up to approximately 60 clinic visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PEX168(200µg)
PEX168(200µg),200µg,Subcutaneous injection,once a week,for 52 weeks.
干预措施: PEX168(200µg) (Drug)
PEX168(100µg)
PEX168(100µg),100µg,Subcutaneous injection,once a week,for 52 weeks.
干预措施: PEX168(100µg) (Drug)
Placebo
Placebo,0.5ml,Subcutaneous injection,once a week for 24 weeks,followed by PEX168(100µg or 200µg) qw sc for 28 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: Baseling to 24 weeks
To evaluate the HbA1c change from baseline to treatment Week 24 when receiving PEX 168 as compared to the placebo, given on the basis of diet control and exercise.
次要结局
- The proportion of HbA1c <6.5% and <7% at the end of the analysis.(Baseling to 24 weeks)
- Fasting plasma glucose(Baseling to 52 weeks)
- 6 points glucose of fingertip(Baseling to 24 and 52 weeks)
- Postprandial blood glucose two hours(Baseling to 24 weeks)
- Postprandial blood glucose two hours AUC(Baseling to 24 weeks)
- Lipid(Baseling to 52 weeks)
- Weight measured by standardized procedure.(Baseling to 52 weeks)
- Blood pressure(Baseling to 52 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Baseling to 56 weeks)